The following data is part of a premarket notification filed by Lightscalpel Llc with the FDA for Lightscalpel Family Of Handpiece Tips For Co2 Surgical Lasers.
| Device ID | K121471 |
| 510k Number | K121471 |
| Device Name: | LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHTSCALPEL LLC 16932 WOOD-RED RD NE STE 201 Woodinville, WA 98072 |
| Contact | Gerald S Palecki |
| Correspondent | Gerald S Palecki LIGHTSCALPEL LLC 16932 WOOD-RED RD NE STE 201 Woodinville, WA 98072 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2012-07-10 |
| Summary: | summary |